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Most people hear about March madness because it is such a

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

big part of sports. March madness is the time when high

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

chool and college basketball tournaments take place all a

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ound the country. That is madness, but only for basketbal

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

fans. The real madness is in December when people are hu

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ting for Christmas gifts.

December is a busy year for re

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ailers and e-tailers. Retail stores are packed with visit

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ors, hours are extended, and items are flying off of the

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

helves. For e-tailers, calls, emails, and orders come in

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

t a rapid pace.

While many celebrate March madness, most

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

only celebrate December madness when it is over. Shoppers

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

hate the long lines, the time it takes to shop, and the l

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ck of parking spaces. Even shopping online can be hard if

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

an item does not fit or takes to long to come.

Retailers

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

and e-tailers make a lot of cash over the holidays but t

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ey find it hard to deal with, just like their customers.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

hey have to increase inventory and deal with sending out

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ore orders, as well as receiving more emails, and taking

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ore calls. To bad December madness is not as great a time

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

as March madness, but luckily it only lasts for one month

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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It's amazing to see so many people who are prepared to sacrifice their lives for the sake of their careers.

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